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NCT03209453 Clinical Trial

Effects of Family Work Shop for Children With Developmental Delays: a Randomized Trial

Development Delay Clinical Trial

Official title:
Therapeutic Effects of Short-term Family-centered Work Shop for Children With Developmental Delays: a Randomized Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT03209453
Other study ID # DOH-SKH-106
Secondary ID
Status Not yet recruiting
Phase N/A
First received July 4, 2017
Last updated July 4, 2017
Start date July 2017
Est. completion date December 2017

Study information
Verified date July 2017
Source Taipei Medical University
Contact Ru-Lan Hsieh
Phone 228332211
Email M001052@ms.skh.org.tw
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To identify the therapeutic effects of short-term family-centered work shop for children with developmental delays

Description:

1. The family work shop has a total of 6 weeks, with 6 families in one course. 2. Two hours per session, one time per week. Aims;

1. Assess the effects of family work shop for children with developmental delays, including functional performance and health-related quality of life.

2. Assess the family strain by work shop for parents of children with developmental delays.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 24
Est. completion date December 2017
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender All
Age group 18 Months to 36 Months
Eligibility Inclusion Criteria:

- 18 M/O to 36 M/O children with developmental delays, under regular rehabilitation programs

Exclusion Criteria:

- less than 18 M/O and older than 36 M/O failed to obtain written informed consent

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• family work shop
Children with developmental delays, under regular rehabilitation programs, participate 6 sessions of family work shop The family work shop had 6 families in one course, 2 hours per week, for a total of 6 weeks.

Locations
Country Name City State
Taiwan Shin Kong Wu Ho-Su Memorial Hospital Taipei

Sponsors (1)
Lead Sponsor Collaborator
Taipei Medical University

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary change from baseline functional performance (scores) at 6 weeks Pediatric Outcome Data Collection Instrument baseline and up to 6 weeks
Secondary change from baseline health-related quality of life (scores) at 6 weeks Child Health Questionnaire baseline and up to 6 weeks
Secondary change from baseline caregiver health-related quality of life (scores) at 6 weeks World Health Organization Quality of Life: brief form baseline and up to 6 weeks
Secondary change from baseline family strain (scores) at 6 weeks Caregiver strain index baseline and up to 6 weeks
Secondary change from baseline family impact Pediatric Quality of Life Inventory: Family impact module baseline and up to 6 weeks
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